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Shuren Fills Alliance in on Fast-Moving Science and CDRH Needs

February 7, 2020

At the Alliance’s request, Dr. Jeffrey Shuren, Director of FDA’s Center for Devices and Radiological Health, met with Alliance members this week to discuss opportunities, challenges, and priorities at CDRH in 2020 and beyond. The Alliance is particularly interested in understanding the level of resources (budget, personnel, infrastructure) the agency (and each Center) needs in order to fulfill its mission and responsibilities.

To provide perspective, Dr. Shuren reviewed the breadth of CDRH’s responsibilities and stressed that the Center is dealing with fast-moving science. Among developed nations, about 50% of med-tech products are approved first in the U.S. CDRH oversees 190,000 types of devices across 21,000 facilities, and 18,000 manufacturers. The volume of review work is such that they approve an average of 12 devices per day. [Steven’s note: The innovation/upgrade cycle in devices is measured in days and months compared to years for drugs and biologics.]

Pointing to the Center’s challenges, Dr. Shuren started with the difficulties of having to implement regulations and laws that are based on a framework first created 40+ years ago. The existing approach to review and approval (with rigid development stages) is a difficult fit for new med/tech and the Center needs more flexibility to reach good decisions that advance innovation and safety together. At the same time, our larger healthcare system is changing (e.g. demand for more home care stimulates demand for new, often networked, medical devices.)

Likewise, the surveillance systems were designed for an earlier era and are being recreated by CDRH to deal with the larger, more global, and more dynamic medical device market that exists today. These systems have to encompass a world of networks, platforms, and constant upgrades that make the market different every day. Those same tools provide an opportunity to have a far more effective surveillance system.

Another challenging area is digital health where advances in the field are not aligned with the regulatory scheme. Device regulation is laden with pre-market requirements that were intended for hardware but don’t fit for software. For example, the traditional clinical trial doesn’t account for iterative changes and “fit for purpose” determinations that are necessary for overseeing digital health.

Dr. Shuren also addressed some of his resource needs. He is focused on assuring CDRH can recruit and retain staff with the educational level and technical abilities to regulate varied and complex technology. The mix is also changing to meet new CDRH challenges (e.g., hiring software engineers). The Center needs more of the salary and recruitment advantages that were part of 21st Century Cures.

Of particular concern is that CDRH has 31 separate IT systems with little ability to interoperate. Dr. Shuren’s goal is to move to four platforms/portals that support the Center’s many needs.  That would permit, among other things, the integration of real world evidence, pre/post market data, and patient input. With the volume of approvals, the Center also needs computing infrastructure to facilitate efficient and thorough review of products.

Two emerging areas were discussed and worth noting. Dr. Shuren wants FDA, and particularly CDRH, to have the artificial intelligence systems necessary to regulate artificial intelligence products. Cybersecurity of medical devices is also an area where move investment needs to be made.

The products that CDRH regulates are becoming ever more sophisticated and have ever shorter innovation/upgrade cycles. A new interoperable IT system is going to be costly, but is also a key to future success of the Center.

Editorial note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.

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